As discussed in Marion Nestle’s book, What to Eat, when preliminary evidence came out associating DHA–an omega-3 fatty acid–with visual and cognitive benefits in young infants, infant formula companies could not wait to begin adding it to their products.

The FDA approved the use of DHA in infant formula on the grounds that it is safe, and companies began selling formula with added DHA, charging a premium for the products and claiming they were better for babies based on the preliminary evidence.  And while FDA established the omega-3 fatty acid was a safe additive in infant formula, according to Nestle the agency did not require the companies to establish that DHA makes any difference in infant health after the first year.


infant-formula-featured.jpgAccording to the FDA Website, the agency does not approve infant formulas before the products can be marketed.  However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula.


Companies now wanting to add other ingredients such as prebiotics, probiotics, lutein, lycopene, and betcarotene have evoked a response from the Center on Budget and Policy Priorities.  The Center, which conducts research and analysis to help shape public debates over proposed budget and tax policies and to help ensure that policymakers consider the needs of low-income families and individuals in these debates, has issued a report on the lack of evidence for the benefits of functional ingredients and the harm they will cause to the economic viability of the U.S. Department of Agriculture’s (USDA’s) assistance program for low income mothers and children, WIC.


About half of the infant formula sold each year in the U.S. is bought by the USDA for the WIC program.


The Center on Budget and Policy Priorities report says, “As pressure mounts to limit federal discretionary spending, it is critical to ensure that WIC not spend funds on foods with functional ingredients that do not deliver clinically significant benefits. WIC spent approximately $850 million on infant formula last year, and a recent USDA study found that more than ten percent of that spending ($91 million annually) is attributable to higher-priced formulas with functional ingredients.  Under current law, the additional cost to WIC of providing foods with these ingredients is likely to grow substantially as such foods proliferate.”


According to the report, formula manufacturers currently do not have to prove that the added ingredients that drive up the price do any good.  The Center on Budget and Policy Priorities stated:

“There is no mechanism within the national WIC program that requires USDA to review the research evidence on the claimed benefits of these functional ingredients or to base decisions about whether to offer foods containing such ingredients on their benefits and the specific needs of WIC participants. Currently, instead, infant formula manufacturers themselves decide whether WIC offers infant formulas with new functional ingredients, while state WIC programs decide whether WIC should offer other foods with such ingredients.”


The leading formula manufacturer, Mead Johnson, admits on its Enfamil Website* that some scientific studies have shown little or no benefit to infant development, lending support to the theory that the inclusion of these oils may just be a marketing gimmick.


“The scientific evidence is mixed. Some studies in infants suggest that including these fatty acids in infant formulas may have positive effects on visual function and neural development over the short term. Other studies in infants do not confirm these benefits. There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist,” according to the FDA’s Infant Formula-Q&A page.


As Nestle points out, “functional foods (and ingredients) are about marketing, not health.  If companies are going to add functional ingredients–and charge higher prices–they need to have some convincing scientific evidence to back up their claims.”



*According to Mead Johnson, manufacturer of Enfamil, studies that do not show functional benefits do not include formulas with at least 0.3% of the total fatty acids DHA.